Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-31
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 673 of 819
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: The smoke ev…
Microtek Medical Inc
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
C.R. Bard, Inc.
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as pre…
Owen Mumford USA, Inc.
Bio-MAC Cannula (Needle) Set
Biologic Therapies, Inc
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and…
GE Healthcare
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
DePuy Orthopaedics, Inc.
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or dege…
Biomet, Inc.
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: T…
Biomet, Inc.
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Roche Diabetes Care, Inc.
Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for u…
Zimmer, Inc.
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrica…
Leonhard Lang Medizintechnik GmbH
Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device i…
King Systems Corp.
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and…
Microtek Medical Inc
LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator and a…
Microtek Medical Inc
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; …
Medical Components, Inc dba MedComp
Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire…
Penner Mfg Inc
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCI…
GE Healthcare
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within…
Ameda, Inc.
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Advanced Sterilization Products
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe …
Zimmer Trabecular Metal Technology, Inc.
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. A…
Becton Dickinson & Company
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theo…
Siemens Healthcare Diagnostics, Inc.
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produc…
Siemens Medical Solutions USA, Inc
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Varia…
Flower Orthopedics Corporation
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments withi…
TITAN SPINE, LLC
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with…
Cardiovascular Systems, Inc.
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone a…
Synthes, Inc.
Alaris PC units, Model No. 8015. Infusion pump.
CareFusion 303, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope I…
Intuitive Surgical, Inc.
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated …
Ameda, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries…
Philips Medical Systems, Inc.
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, th…
RAYSEARCH LABORATORIES AB
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to con…
Ossur H / F
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended fo…
Leica Microsystems, Inc.
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicate…
Aaren Scientific, Incorporated
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope…
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Contr…
Intuitive Surgical, Inc.
GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
GE Inspection Technologies, LP
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Brainlab AG
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
In2Bones, SAS
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Roche Molecular Systems, Inc.
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in…
ArthroCare Medical Corporation
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
In2Bones, SAS
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
GE Inspection Technologies, LP
Blinds To Go Recalls Window Shades Due to Strangulation Hazard
Blinds To Go of Lakewood, New Jersey
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent great…
LeMaitre Vascular, Inc.
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to meas…
Transonic Systems Inc
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Dis…
CooperSurgical, Inc.
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field …
GE Healthcare
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all availa…
Siemens Medical Solutions USA, Inc
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.